The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00724139
• Other study ID #: protocol # 078
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2008
• Last updated: July 28, 2008
• Start date: January 2008
• Est. completion date: May 2009

Study information

• Verified date: July 2008
• Source: HaEmek Medical Center, Israel
• Contact: Amir Haim, MD
• Phone: 0524262129
• Email: amirhaim[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns.

The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain.

The second hypothesis of the project is that repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning thus conveying plasticity of existing locomotor patterns and gait strategies.

Description:

Design: Prospective, case control Setting: subjects will undergo a tailored training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms (APOS system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel) which conveys perturbation throughout the gait sickle. Pre and post training level walking will be examined via: (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 4 different settings Patients will then participate in continued biomechanical perturbation training for 3-6 month and will then undergo a second gait examination Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: None Accepts patients suffering from medial compartment knee osteoarthritis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria:

1. Community-dwelling older adults.

2. Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren & Lawrence scale.

3. Ambulatory and active patients that can precipitate the gait analysis.

4. Age 50-75.

5. No prior joint replacement in the lower extremity.

Exclusion Criteria:

• Exclusion Criteria:

• Knee pain due to pathologic conditions other than OA, such as rheumatoid arthritis and pseudogout.

• Knee with flexion contracture greater than 20°.

• Patients with hip problems, symptomatic lumbar spine disease, spinal cord.

• Ataxic gait related to neurologic disease.

• Patients with increased tendency to fall.

• Lack of physical or mental ability to perform or comply with the treatment procedure.

• Diabetes mellitus.

• History of pathological osteoporotic fracture.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel
training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle

Locations

Country	Name	City	State
Israel	Technion Israel institute of technology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain		6 months	No
Secondary	would repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning		6 months	No